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294 result(s) for "Vivarelli, Marco"
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Liver transplantation in hepatocellular carcinoma after tumour downstaging (XXL): a randomised, controlled, phase 2b/3 trial
Indications for liver transplantation for hepatocellular carcinoma are evolving and so-called expanded criteria remain debated. Locoregional therapies are able to downstage hepatocellular carcinoma from beyond to within the Milan criteria. We aimed to investigate the efficacy of liver transplantation after successful hepatocellular carcinoma downstaging. We did an open-label, multicentre, randomised, controlled trial designed in two phases, 2b and 3, at nine Italian tertiary care and transplantation centres. Patients aged 18–65 years with hepatocellular carcinoma beyond the Milan criteria, absence of macrovascular invasion or extrahepatic spread, 5-year estimated post-transplantation survival of at least 50%, and good liver function (Child-Pugh A-B7) were recruited and underwent tumour downstaging with locoregional, surgical, or systemic therapies according to multidisciplinary decision. After an observation period of 3 months, during which sorafenib was allowed, patients with partial or complete responses according to modified Response Evaluation Criteria in Solid Tumors were randomly assigned (1:1) by an interactive web-response system to liver transplantation or non-transplantation therapies (control group). A block randomisation (block size of 2), stratified by centre and compliance to sorafenib treatment, was applied. Liver transplantation was done with whole or split organs procured from brain-dead donors. The control group received sequences of locoregional and systemic treatment at the time of demonstrated tumour progression. The primary outcomes were 5-year tumour event-free survival for phase 2b and overall survival for phase 3. Analyses were by intention to treat. Organ allocation policy changed during the course of the study and restricted patient accrual to 4 years. This trial is registered with ClinicalTrials.gov, NCT01387503. Between March 1, 2011, and March 31, 2015, 74 patients were enrolled. Median duration of downstaging was 6 months (IQR 4–11). 29 patients dropped out before randomisation and 45 were randomly assigned: 23 to the transplantation group versus 22 to the control group. At data cutoff on July 31, 2019, median follow-up was 71 months (IQR 60–85). 5-year tumour event-free survival was 76·8% (95% CI 60·8–96·9) in the transplantation group versus 18·3% (7·1–47·0) in the control group (hazard ratio [HR] 0·20, 95% CI 0·07–0·57; p=0·003). 5-year overall survival was 77·5% (95% CI 61·9–97·1) in the transplantation group versus 31·2% (16·6–58·5) in the control group (HR 0·32, 95% CI 0·11–0·92; p=0·035). The most common registered grade 3–4 serious adverse events were hepatitis C virus recurrence (three [13%] of 23 patients) and acute transplant rejection (two [9%]) in the transplantation group, and post-embolisation syndrome (two [9%] of 22 patients) in the control group. Treatment-related deaths occurred in four patients: two (8%) of 23 patients in the transplantation group (myocardial infarction and multi-organ failure) versus two (9%) of 22 patients in the control group (liver decompensation). Although results must be interpreted with caution owing to the early closing of the trial, after effective and sustained downstaging of eligible hepatocellular carcinomas beyond the Milan criteria, liver transplantation improved tumour event-free survival and overall survival compared with non-transplantation therapies Post-downstaging tumour response could contribute to the expansion of hepatocellular carcinoma transplantation criteria. Italian Ministry of Health.
Robotic versus laparoscopic resections of posterosuperior segments of the liver: a propensity score-matched comparison
Background Open parenchymal-preserving resection is the current standard of care for lesions in the posterosuperior liver segments. Laparoscopy and robot-assisted surgery are emergent surgical approaches for liver resections, even in posteriorly located lesions. The objective of this study was to compare robot-assisted to laparoscopic parenchymal-preserving liver resections for lesions located in segments 7, 8, 4a, and 1. Methods Demographics, comorbidities, clinicopathologic characteristics, surgical treatments, and outcomes from patients who underwent laparoscopic and robot-assisted liver resection in two centers for lesions in the posterosuperior segments between June 2008 and February 2014 were reviewed. A 1:2 matched propensity score analysis was performed by individually matching patients in the robotic cohort to patients in the laparoscopic cohort based on demographics, comorbidities, performance status, tumor stage, location, and type of resection. Results Thirty-six patients who underwent robot-assisted liver resection were matched with 72 patients undergoing laparoscopic liver resection. Matched patients displayed no significant differences in postoperative outcomes as measured by blood loss, hospital stay, R0 negative margin rate, and mortality. The overall morbidity according to the comprehensive complication index was also similar (34.6 ± 33 vs. 18.4 ± 11.3, respectively, for robotic and laparoscopic approach, p  = 0.11). Patients undergoing robotic liver surgery had significantly longer inflow occlusion time (77 vs. 25 min, p  = 0.001) as compared with their laparoscopic counterparts. Conclusions Although number and severity of complications in the robotic group appears to be higher, robotic and laparoscopic parenchymal-preserving liver resections in the posterosuperior segments display similar safety and feasibility.
Innovation, Employment and Skills in Advanced and Developing Countries: A Survey of Economic Literature
I discuss the theoretical and empirical literature on the quantitative and qualitative employment impact of technological change. I also compare the relative explanatory power of competing economic theories, while detailing the macro, sectoral, and micro evidence on the issue with reference to advanced and developing economies. The main purpose of the paper is to offer a critical meta-analysis of both the theory and recent empirical achievements stemming from the relationship of technology and employment. More specifically, I draw some general conclusions about possible consequences of that relationship.
Globalization, technological change and labor demand: a firm-level analysis for Turkey
This paper studies the interlinked relationship between globalization and technological upgrading in affecting employment and wages of skilled and unskilled workers in a middle income developing country. It exploits a unique longitudinal firm-level database that covers all manufacturing firms in Turkey over the 1992–2001 period. Turkey is taken as an example of a developing economy that, in that period, had been technologically advancing and becoming increasingly integrated with the world market. The empirical analysis is performed at firm level within a dynamic framework using a model that depicts the employment and wage trends for skilled and unskilled workers separately. In particular, the System Generalized Method of Moments (GMM-SYS) procedure is applied to a panel dataset of about 15,000 firms. Our results confirm the theoretical expectation that developing countries face the phenomena of skill-biased technological change and skill-enhancing trade, both leading to increasing the employment and wage gap between skilled and unskilled workers. In particular, a strong evidence of a relative skill bias emerges: both domestic and imported technologies increase the relative demand for skilled workers more than the demand for the unskilled. \"Learning by exporting\" also appears to have a relative skill- biased impact, while FDI imply an absolute skill bias.
Laparoscopic versus open right posterior sectionectomy: an international, multicenter, propensity score-matched evaluation
BackgroundAlthough laparoscopic liver resection has become the standard for minor resections, evidence is lacking for more complex resections such as the right posterior sectionectomy (RPS). We aimed to compare surgical outcomes between laparoscopic (LRPS) and open right posterior sectionectomy (ORPS).MethodsAn international multicenter retrospective study comparing patients undergoing LRPS or ORPS (January 2007—December 2018) was performed. Patients were matched based on propensity scores in a 1:1 ratio. Primary endpoint was major complication rate defined as Accordion ≥ 3 grade. Secondary endpoints included blood loss, length of hospital stay (LOS) and resection status. A sensitivity analysis was done excluding the first 10 LRPS patients of each center to correct for the learning curve. Additionally, possible risk factors were explored for operative time, blood loss and LOS.ResultsOverall, 399 patients were included from 9 centers from 6 European countries of which 150 LRPS could be matched to 150 ORPS. LRPS was associated with a shorter operative time [235 (195–285) vs. 247 min (195–315) p = 0.004], less blood loss [260 (188–400) vs. 400 mL (280–550) p = 0.009] and a shorter LOS [5 (4–7) vs. 8 days (6–10), p = 0.002]. Major complication rate [n = 8 (5.3%) vs. n = 9 (6.0%) p = 1.00] and R0 resection rate [144 (96.0%) vs. 141 (94.0%), p = 0.607] did not differ between LRPS and ORPS, respectively. The sensitivity analysis showed similar findings in the previous mentioned outcomes. In multivariable regression analysis blood loss was significantly associated with the open approach, higher ASA classification and malignancy as diagnosis. For LOS this was the open approach and a malignancy.ConclusionThis international multicenter propensity score-matched study showed an advantage in favor of LRPS in selected patients as compared to ORPS in terms of operative time, blood loss and LOS without differences in major complications and R0 resection rate.
Laparoscopic Versus Open Approach for Formal Right and Left Hepatectomy: A Propensity Score Matching Analysis
Background Laparoscopic liver surgery is expanding worldwide, but further evidence is needed to assess safety and efficacy of laparoscopic major hepatectomy. The study analyzes perioperative outcomes of pure laparoscopic versus open major hepatectomies matched by the propensity score method. Methods From 2005 to 2017, 268 major hepatectomies were performed of which 73 were laparoscopic. After a 1:1 propensity score matching, 59 laparoscopic right and left hepatectomies were compared to 59 open. The matching was based on age, gender, year of procedure, BMI, ASA score, underlying liver disease, previous abdominal surgery, type of hepatectomy, preoperative chemotherapy, number, dimension and nature of lesions. An intention-to-treat analysis and a per-protocol analysis were carried out. Results Mean surgical time was 315 min in the laparoscopic group and 292.5 min in the open group ( p  = 0.039); conversion rate in laparoscopy was 20.3%; blood loss was 480 ml (50–3000) versus 550 ml (50–2600), respectively, for laparoscopic and open ( p  = 0.577). Lengths of postoperative analgesia and hospital stay were shorter in the laparoscopic group ( p  = 0.0001 and 0.024, respectively). Postoperative complications occurred in 11.9% of laparoscopic cases and in 25.4% of open cases ( p  = 0.098). Median Comprehensive Complication Index was 26.2 (8.7–54.2) in the open group versus 20.9 (8.7–66.2) in open ( p  = 0.368). Per-protocol analysis showed a better trend in favor of laparoscopy concerning surgical time. Conclusions Laparoscopic major hepatectomies are safe and feasible procedures allowing a similar complication rate with a shorter hospital stay and diminished postoperative pain with respect to the standard approach.
ALPPS Procedure for Extended Liver Resections: A Single Centre Experience and a Systematic Review
To report a single-centre experience with the novel Associating Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS) technique and systematically review the related literature. Since January 2013, patients with extended primary or secondary liver tumors whose future liver remnant (FLR) was considered too small to allow hepatic resection were prospectively assessed for the ALPPS procedure. A systematic literature search was performed using PubMed, Scopus and the Cochrane Library Central. Until July 2014 ALPPS was completed in 9 patients whose mean age was 60 ± 8 years. Indications for surgical resection were metastases from colorectal cancer in 3 cases, perihilar cholangiocarcinoma in 3 cases, intrahepatic cholangiocarcinoma in 2 cases and hepatocellular carcinoma without chronic liver disease in 1 case. The calculated FLR volume was 289 ± 122 mL (21.1 ± 5.5%) before ALPPS-1 and 528 ± 121 mL (32.2 ± 5.7%) before ALLPS-2 (p < 0.001). The increase in FLR between the two procedures was 96 ± 47% (range: 24-160%, p < 0.001). Additional interventions were performed in 4 cases: 3 patients underwent Roux-en-Y hepaticojejunostomy, and one case underwent wedge resection of a residual tumor in the FLR. The average time between the first and second step of the procedure was 10.8 ± 2.9 days. The average hospital stay was 24.1 ± 13.3 days. There was 1 postoperative death due to hepatic failure in the oldest patient of this series who had a perihilar cholangiocarcinoma and concomitant liver fibrosis; 11 complications occurred in 6 patients, 4 of whom had grade III or above disease. After a mean follow-up of 17.1 ± 8.5 months, the overall survival was 89% at 3-6 and 12 months. The recurrence-free survival was 100%, 87.5% and 75% at 3-6-12 months respectively. The literature search yielded 148 articles, of which 22 articles published between 2012 and 2015 were included in this systematic review. The ALPPS technique effectively increased the resectability of otherwise inoperable liver tumors. The postoperative morbidity in our series was high in accordance with the data from the systematic review. Age, liver fibrosis and presence of biliary stenting were predisposing factors for postoperative morbidity and mortality.
Clinical and epidemiological characteristics of KPC-producing Klebsiella pneumoniae from bloodstream infections in a tertiary referral center in Italy
Background Bloodstream infections (BSI) due to Klebsiella pneumoniae carbapenemase (KPC)-producing K. pneumoniae (KPC-Kp) have become an important problem and they are associated with a high mortality rate. The aim of our study was to evaluate the clinical and epidemiological characteristics of KPC-Kp from BSIs. Methods In this retrospective cohort study, conducted in a tertiary referral center in Italy, 112 patients with KPC-Kp BSIs diagnosed between February 2011 and December 2015 were identified. We evaluated the mortality at 30 days from the first positive blood culture. Survivor and non-survivor subgroups were compared to identify predictors of mortality. Results The overall crude mortality was 35%. APACHE II score ≥ 15, septic shock at BSI onset, immunosuppressive therapy during the 30 days before the BSI onset, and the lack of a combination therapy with at least 2 active drugs emerged as independent predictors of mortality. Excluding patients with inadequate therapy, the mortality decreased to 25% while an APACHE II score ≥ 15 and the presence of septic shock remained independently associated with a negative outcome. Two different pulsotypes were identified: pulsotype A belonged to ST512 and carried KPC-3 and pulsotype B belonged to ST307 and carried KPC-2. Conclusions This study confirmed a high mortality rate of KPC-Kp BSIs. The outcome is heavily influenced by the patient’s clinical conditions. A therapeutic approach including a combination with at least two active drugs in vitro can improve the prognosis, unless patients received an appropriate therapy.
Imported technology and manufacturing employment in Ethiopia
There is a dearth of research on the impact of technological change over employment in least developed countries (LDCs) embarking on globalization and consequent international technological transfer. Using a panel of 1940 Ethiopian firms over the period 1996–2004 and deploying GMM-SYS estimates, this paper aims to establish the role played by trade, FDI and technology in affecting employment and skills. The results obtained lend support to a labour–augmenting effect. Moreover, the implemented two-equation dynamic framework provides evidence of a skill-bias specific to those enterprises with higher share of foreign ownership and located in the vicinity of the capital city.
To be born is not enough: the key role of innovative start-ups
This paper investigates the reasons why entry per se is not necessarily good and the evidence showing that innovative start-ups survive longer than their non-innovative counterparts. In this framework, our own empirical analysis shows that greater survival is achieved when start-ups engage successfully in both product innovation and process innovation, with a key role of the latter. Moreover, this study goes beyond a purely microeconomic perspective and discusses the key role of the environment within which innovative entries occur. What shown and discussed in this contribution strongly supports the proposal that the creation and survival of innovative start-ups should become one qualifying point of the economic policy agenda.